Methods and devices for delivery of a prosthetic valve

ABSTRACT

A valve prosthesis and a system for delivering a valve prosthesis are described herein. The system can include a support frame, a valve anchor comprising an anchoring leg and a plurality of U-shaped members, and a suture coupled to the support frame and slidably coupled to the anchoring leg.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of and priority to U.S.Provisional Application No. 62/614,488, filed on Jan. 7, 2018, and thepresent application is also a continuation-in-part of U.S.Non-Provisional Application Ser. No. 14/774,037, filed on Sep. 9, 2015,which is a U.S. National Stage Entry of International Application No.PCT/US2014/029315, filed on Mar. 14, 2014, which claims the benefit ofand priority to U.S. Provisional Application No. 61/784,973, filed onMar. 14, 2013, the entireties of each of which are incorporated hereinby reference.

TECHNICAL FIELD

The present subject matter described herein relates to prosthetic heartvalve delivery systems and methods for transcatheter delivery of a valvethrough the venous system.

BACKGROUND

Prosthetic heart valves are used to replace damaged or diseased heartvalves. In vertebrate animals, the heart is a muscular organ with fourpumping chambers: the left and right atria and the left and rightventricles each provided with its own one-way valve. The natural heartvalves are identified as the aortic, mitral (or bicuspid), tricuspid andpulmonary valves. Prosthetic heart valves can be used to replace any ofthese naturally occurring valves, although repair or replacement of theaortic or mitral valves is more common since they reside in the leftside of the heart where pressures are the greatest.

A conventional heart valve replacement surgery involves accessing theheart in the patient's thoracic cavity through a longitudinal incisionin the chest. For example, a median sternotomy requires cutting throughthe sternum and forcing the two opposing halves of the rib cage to bespread apart, allowing access to the thoracic cavity and heart within.The patient is then placed on cardiopulmonary bypass, which involvesstopping the heart to permit access to the internal chambers. Suchopen-heart surgery is particularly invasive and involves a lengthy anddifficult recovery period.

Percutaneous delivery of an aortic valve has recently emerged as apromising alternative to surgical valve replacement. Presently,transcatheter implantation is accomplished by a transfemoral pathwaywith retrograde access to the native aortic valve. This minimallyinvasive aortic valve replacement has resulted in decreasedhospitalization, reduction in sternal wound complications, reducedsurgical trauma and improved cosmesis. Despite the success oftranscatheter delivery through the femoral artery, there are significantdrawbacks, especially in the elderly population, which is a populationthat benefits greatly from minimally invasive procedures.

In some patients, arterial diameter is too small to safely accommodatepassage of a delivery system due to the buildup of plaque and thepresence of stents previously implanted. Dislodging of plaque materialduring a transcatheter procedure can result in generation of embolileading to risk of stroke. Accordingly, it is desirable to deviseadditional systems to allow transcatheter delivery of a valve prosthesisthrough the venous system, which generally has a larger inner diameterand can better accommodate the compact delivery system.

The foregoing examples of the related art and limitations relatedtherewith are intended to be illustrative and not exclusive. Otherlimitations of the related art will become apparent to those of skill inthe art upon a reading of the specification and a study of the drawings.

SUMMARY

The following aspects and some embodiments thereof described andillustrated below are meant to be exemplary and illustrative, notlimiting in scope.

Transcatheter delivery of a valve prosthesis to the heart traditionallyinvolves delivery through the vena cava and through the chambers of theheart. Due to the heart structure, such delivery requires that thesystem catheters be able to maneuver tight turns without damaging thesurrounding tissue or the system itself. Described below are prostheticvalve delivery systems, valve prostheses, and methods of using the same,which provide increased flexibility for such transcatheter delivery inaddition to the reduced diameter, which makes transcatheter deliverypossible. Further, such systems, valve prostheses, and methods permit aclinician to more easily control expansion, placement, and release of avalve prosthesis. Further, some embodiments provide for systems andvalve prostheses that can be delivered in a radially compact deliveryconfiguration that achieves numerous advantages over conventionalsystems and devices, as described herein.

Some embodiments disclosed herein provide a delivery system fordelivering a valve prosthesis. The valve prosthesis can comprise aradially expandable valve anchor, a support frame positionable withinthe valve anchor, and a plurality of valve leaflets coupled to thesupport frame. The delivery system can comprise a core member and anengagement mechanism for releasably engaging the valve anchor. Theengagement mechanism can optionally be slidably coupled to the coremember. The engagement mechanism can engage with a lock component, whichcan optionally be slidably coupled along the core member. Accordingly,in some embodiments, the engagement mechanism can be displaced or movedrelative to the core member to releasably engage one or more features ofthe valve prosthesis. The engagement mechanism can permit one or moreaspects of the valve anchor to radially expand while radiallyrestricting expansion of or engaging with one or more adjacent aspectsof the support frame.

For example, in some embodiments, the delivery system can engage one ormore anchoring legs of the valve anchor with an engagement mechanismwhile being disengaged from one or more U-shaped member, anchoringmember, valve clasper, sinus locator, valve positioner, or valve hangersof the valve anchor. The U-shaped members can each comprise a baseportion that can be used to engage with certain aspects of the nativevalve structure, such as the aortic sinus, including the posterioraortic sinus, the left aortic sinus, and/or the right aortic sinus, of anative aortic valve. The base portions can have rounded or atraumaticshapes that permit the base portions to be expanded and fitted intorespective sinuses of the valve. Accordingly, in some embodiments, thedelivery system can engage one or more anchoring legs of the valveanchor while the base portions of the U-shaped members expand relativeto the one or more anchoring legs, thereby allowing a clinicianmanipulate or move the base portions relative to the native valvestructure to properly seat the valve anchor relative to the native valvestructure.

In some embodiments, the base portions and the anchoring legs can extendin a longitudinal direction along the valve anchor. For example, thevalve anchor can comprise three base portions and three anchoring legs.Each of the anchoring legs can be interconnected with and alternatinglyinterposed between respective base portions. First end sections of theanchoring legs can be interconnected with respective first end sectionsof the base portions. Further, second end sections of the anchoring legscan be releasably couplable to the delivery system using the engagementmechanism while second end sections of the U-shaped members (or baseportions) can move independently of the second end sections of theanchoring legs (i.e., the second end sections of the anchoring legs maybe coupled to the delivery system and the base portions of the U-shapedmembers can expand relative to the engaged second end sections of theanchoring legs).

Optionally, in some embodiments, the second end sections or baseportions of the U-shaped members can be maintained in a compressedconfiguration using a sheath. For example, the sheath can be slidablypositioned over the valve anchor and be retractable in order to permitthe U-shaped members of the valve anchor to expand relative to theanchoring legs. Thereafter, the clinician can maneuver the base portionsof the U-shaped members into position relative to the native valvestructure. Once the base portions are properly positioned relative tothe native valve structure (e.g., at a desired final position), theanchoring legs can be disengaged, thereby permitting the valve anchor tofully expand and be released from the delivery system. Once the valveanchor is seated or positioned relative to the native valve structure,the support frame can be positioned longitudinally within the lumen ofthe valve anchor, expanded, and released into engagement with the valveanchor. Other features and steps of the delivery system, the valveanchor, and methods of assembling and delivering the valve prosthesisare discussed further herein.

In accordance with some embodiments, the engagement mechanism cancomprise a pin assembly. The pin assembly can include (i) a tubularcomponent having current proximal and distal sections, and (ii) at leastone pin coupled to the distal section. The pin can extend proximallyfrom the distal section toward the proximal section and be radiallyspaced apart from the tubular component.

In some embodiments, the lock component can include at least one lockaperture (i) proximal to the tubular component distal section and (ii)configured to permit the at least one pin to extend therethrough.

Optionally, the valve anchor can include at least one anchoring leg. Theanchoring leg can have a coupling portion with a connection aperturedisposed therethrough to permit the engagement mechanism to engage theanchoring leg.

For example, in an engaged configuration, the tubular component distalsection can be axially spaced apart from the lock component at a firstdistance to permit the at least one pin to extend through the connectionaperture of the anchoring leg and the lock component lock aperture tointerconnect the valve anchor leg with the engagement mechanism. Thus,in the engaged position, the anchoring leg can be engaged with the pinand interposed between the tubular component distal section and the lockcomponent. In a released configuration, the tubular component distalsection can be axially spaced apart from the lock component at a seconddistance, greater than the first distance, to position or release the atleast one pin outside of the lock aperture to permit the anchoring legto disengage from the at least one pin.

In accordance with some embodiments, methods for delivering a valveprosthesis to a target location in a vessel of a subject can includeintroducing a delivery system into the vessel to position a valve anchorat the target location. A sheath of the delivery system can beproximally retracted to permit the U-shaped members of the valve anchorto expand at the target location for positioning the valve anchorrelative to the native valve structure. Once the base portions of theU-shaped members are engaged or seated within respective valve sinuses,for example, the anchoring legs of the valve anchor can be released topermit the valve anchor to fully expand within the native valvestructure. Thereafter, a support frame of the valve prosthesis can bepositioned within a lumen of the valve anchor, expanded, and engagedwith the valve anchor. The delivery system can thereafter be removedfrom the patient.

Optionally, the valve anchor can be released by disengaging anengagement mechanism of the delivery system. For example, the engagementmechanism can comprise a pin assembly that engages with one or moreanchoring legs of the valve anchor. The pin assembly can comprise a lockpin carrier that is coupled to a plurality of pins. In order todisengage the engagement mechanism, the lock pin carrier can becontacted by a lock activator in order to move the lock pin carrierrelative to the anchoring legs in order to slide the pins out ofengagement with the anchoring legs. The lock pin carrier can slide alongand relative to a core member of the delivery system.

In some embodiments, the delivery system can comprise a nose cone havingan engagement area and a plurality of apertures through which the pinscan extend to permit the anchoring legs of the valve anchor to beengaged and restrained within the engagement area.

Optionally, the lock pin carrier can be at least partially disposedwithin a cavity of the nose cone and slide there within in order to movethe pins into or out of the engagement area. For example, when the lockactivator contacts the lock pin carrier, the lock pin carrier can bedistally advanced relative to the engagement area of the nose cone,thereby withdrawing the pins from the engagement area and disengagingthe pins from the anchoring legs of the valve anchor.

Accordingly, various embodiments can be provided in which movement ofthe engagement mechanism can cause disengagement of the delivery systemfrom the anchoring legs of the valve anchor, thereby permitting releaseof the valve anchor from the delivery system.

Additional embodiments of the present devices and methods, and the like,will be apparent from the following description, drawings, examples, andclaims. As can be appreciated from the foregoing and followingdescription, each and every feature described herein, and each and everycombination of two or more of such features, is included within thescope of the present disclosure provided that the features included insuch a combination are not mutually inconsistent. In addition, anyfeature or combination of features may be specifically excluded oromitted from any embodiment of the present disclosure. Additionalaspects and advantages of the present disclosure are set forth in thefollowing description and claims, particularly when considered inconjunction with the accompanying examples and drawings.

Additional features and advantages of the subject technology will be setforth in the description below, and in part will be apparent from thedescription, or may be learned by practice of the subject technology.The advantages of the subject technology will be realized and attainedby the structure particularly pointed out in the written description andembodiments hereof as well as the appended drawings.

Certain features of valve prostheses, delivery devices, actuationhandles, other devices, systems, and methods which can be implementedwith the valve prostheses, delivery devices, actuation handles, otherdevices, systems, and methods discussed in the present disclosure, canimplement features of and/or be used in combination with other featuresof valve prostheses, delivery devices, actuation handles, other devices,systems, and methods described for example in International ApplicationNo. PCT/US2019/012406, entitled HEART VALVE PROSTHESIS AND DELIVERY,filed on Jan. 4, 2019, by Ji Zhang, Brandon G. Walsh, Cheng Yong Yang,Jinhua Zhu, and Dennis Michael McMahon, and in International ApplicationNo. PCT/US2019/012408, entitled PROSTHETIC HEART VALVE DELIVERY SYSTEM,filed on Jan. 4, 2019, by Ji Zhang, Brandon G. Walsh, and Cheng YongYang, the entirety of each of which is incorporated herein by reference.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the subject technology.

BRIEF DESCRIPTION OF THE DRAWINGS

The following figures are included to illustrate certain aspects of thepresent disclosure, and should not be viewed as exclusive embodiments.The subject matter disclosed is capable of considerable modifications,alterations, combinations, and equivalents in form and function, withoutdeparting from the scope of this disclosure.

FIG. 1 illustrates a cross-sectional view of a human heart, and inparticular, the implantation of an aortic valve prosthesis into a nativevalve structure of the heart, according to some embodiments.

FIG. 2 illustrates a delivery system in a delivery configuration fordelivering the valve prosthesis, including a radially expandable valveanchor and a support frame, using an engagement mechanism for releasableengaging the expandable valve anchor, according to some embodiments.

FIG. 3A is an illustration of a nose cone of the valve anchor of thedelivery system of FIG. 2, according to some embodiments.

FIG. 3B illustrates a cross-sectional view of the nose cone of the valveof FIG. 3, according to some embodiments.

FIG. 4A illustrates a pin assembly of the delivery system of FIG. 2,according to some embodiments.

FIG. 4B illustrates an alternative pin assembly, according to someembodiments.

FIG. 5A illustrates a pusher component of the delivery system of FIG. 2,according to some embodiments.

FIG. 5B illustrates an alternative pusher component, according to someembodiments.

FIG. 6A illustrates the support frame and the valve anchor housed in acompact state within a sheath of the delivery system of FIG. 2,according to some embodiments.

FIG. 6B illustrates the valve anchor in an expanded configuration,partially released from the sheath and engaged with the engagementmechanism, which is in a pre-released configuration, according to someembodiments.

FIG. 6C illustrates the distal advancement of the support frame and apusher component of the engagement mechanism to initiate disengagementof the valve anchor from the engagement device, according to someembodiments.

FIG. 6D illustrates the valve anchor and the engagement mechanism in areleased configuration, prior to release of the support frame from thesheath of the delivery system, according to some embodiments.

FIG. 6E illustrates the sheath being proximally retracted to permit thevalve prosthesis to begin expansion, according to some embodiments.

FIG. 6F illustrates the valve prosthesis fully expanded within the valveanchor, according to some embodiments.

FIGS. 7A-7F illustrate steps in a method for delivering the valveprosthesis through the aorta to the native aortic valve using a valveprosthesis delivery system, according to some embodiments.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are setforth to provide a full understanding of the subject technology. Itshould be understood that the subject technology may be practicedwithout some of these specific details. In other instances, well-knownstructures and techniques have not been shown in detail so as not toobscure the subject technology.

Further, while the present disclosure sets forth specific details ofvarious embodiments, it will be appreciated that the description isillustrative only and should not be construed in any way as limiting.Additionally, it is contemplated that although particular embodiments ofthe present disclosure may be disclosed or shown in the context ofmitral valve prostheses, such embodiments may be used in other cardiacvalve prosthesis applications. Furthermore, various applications of suchembodiments and modifications thereto, which may occur to those who areskilled in the art, are also encompassed by the general conceptsdescribed herein.

As with all cardiac valves, a healthy aortic valve will open to allowblood flow and close to prevent backflow of blood. However, disease anddysfunction of the valve can result in regurgitation or decreased bloodflow. In such cases, a replacement valve prosthesis must be used toperform the functions of a healthy aortic valve.

However, there are numerous challenges in providing a replacement valveprosthesis. For example, in order to overcome the problem ofregurgitation or decreased blood flow, a suitable replacement valveprosthesis must provide an acceptable seal and anchoring against thenative valve tissue when positioned and released against the nativevalve structure, such as the native valve annulus. Further, thearchitecture of the aortic valve annulus also creates a challenge in thedesign of an aortic valve prosthesis. Indeed, the aortic valveprosthesis must conform to the unique anatomical structure of the aorticvalve and remain anchored in the presence of the continuous contractionsof a functioning heart.

The present disclosure describes systems, devices, and methods forimplanting an aortic valve prosthesis using a minimally invasivesurgical technique. The systems accommodate the complex structure of theaortic valve to ensure that the implanted valve prosthesis is properlypositioned and securely maintained in place after implantation. Further,some embodiments also provide an aortic valve prosthesis delivery systemthat can comprise an aortic valve prosthesis.

The valve prosthesis can comprise an expandable valve anchor, a supportframe that can be coupled to the valve anchor, and a plurality of valveleaflets coupled to the support frame. The implant can have a pluralityof prosthetic valve leaflets attached to an internal surface thereofthat can mimic the function of a native aortic valve. The implant andvalve anchor can have a compact configuration for delivery to a diseasedvalve, and an unfolded or expanded configuration upon release andimplantation in the diseased valve annulus. Moreover, in someembodiments, the implant and the valve anchor can be positioned relativeto each other to minimize the diameter of the valve component duringdelivery.

Further, in some embodiments, the implant can be flexibly coupled to thevalve anchor to provide efficient positioning of both the valve anchorand the implant. For example, the implant and the valve anchor can beconnected by a flexible element such that prior to releasing andexpanding the valve component in the heart or native valve structure,the implant and the valve anchor can be longitudinally or rotationallydisplaced relative to one another. Further, the implant and the valveanchor can expand from a compact state to an expanded state, and in someembodiments, independently of each other.

FIG. 1 illustrates a cross-sectional view of a human heart in which anaortic valve prosthesis has been implanted in a native valve structureof the heart. The heart 10 can comprise a right atrium 12, a rightventricle 14, a left ventricle 16, and a left atrium 18. Oxygen-depletedblood enters the right atrium 12 through the superior and inferior venacava 20, 22. The oxygen-depleted blood is pumped from the right atrium,through a tricuspid valve 24, which separates the right atrium 12 fromthe right ventricle 14, and into the right ventricle 14. The rightventricle 14 then pumps the oxygen-depleted blood through a pulmonaryvalve 26 and into pulmonary arteries 28 that direct the oxygen-depletedblood to the lungs for oxygen transfer to the oxygen-depleted blood.Thereafter, oxygen-rich blood is transported from the lungs throughpulmonary veins 30 to the left atrium 18. The oxygen-rich blood ispumped from the left atrium 18 through a mitral valve 32 and into theleft ventricle 16. The left ventricle 16 then pumps the oxygen-richblood through an aortic valve 34 and into the aorta 36. The oxygen-richblood is carried by the aorta to a series of arteries that transport theblood to various organs in the body.

Implantation of a prosthetic aortic valve via a minimally invasivetranscatheter approach may be accomplished, e.g., through the femoralartery and aortic arch into the left atrium or through the femoral veinand inferior vena cava by way of a transseptal punch. The aortic valve,between the left atrium and left ventricle, may be the most difficultvalve to repair percutaneously because it can be difficult to reach.Although the aortic valve can be reached via the left ventricle andmitral valve, manipulation of catheters that have to make twoapproximately 180° turns is cumbersome. However, as discussed herein,various embodiments are provided that allow a clinician to overcomethese disadvantages and effectively deliver a prosthetic valve to atarget location in the heart.

Delivery Systems for the Valve Prosthesis

The present disclosure provides devices, systems, and methods for valvereplacement, preferably using a minimally invasive surgical technique.While the systems and methods will have application in a number ofdifferent vessels in various parts of the body, they are particularlywell suited for replacement of a malfunctioning cardiac valve, and inparticular an aortic valve. The systems and methods will also haveapplication in other malfunctioning cardiac valves, e.g., a pulmonaryvalve or a mitral valve.

The systems and methods disclosed herein can be particularlyadvantageous in their ability to provide a more flexible prostheticheart valve delivery system, ensure accurate and precise placement ofthe prosthetic heart valve or valve prosthesis with reduced reliance onimaging, and provide additional anchoring of the valve prosthesis,reducing the incidence of valve migration.

Another advantage of the systems and methods disclosed herein is theability to deliver and implant the valve prosthesis through the aorta,which has a smaller diameter than the inferior vena cava, through whichsurgeons typically proceed to access the heart.

The present disclosure also provides improved systems and methods forimplanting a prosthetic heart valve. In particular, improved minimallyinvasive methods and systems are provided for retrograde implantation ofexpansible prosthetic heart valves within or adjacent a valved anatomicsite within the heart. In particular, the improved prosthetic heartvalve delivery systems and methods of the present disclosure providemore flexibility in the valve replacement procedure, ensure accurate andprecise placement of the prosthetic heart valve with reduced reliance onimaging, and provide additional anchoring of the prosthetic valve,reducing the incidence of valve migration or misalignment.

Various embodiments of the disclosure are directed to a delivery systemcapable of maneuvering tight turns, and including a compactly configuredvalve prosthesis, which can comprise a valve anchor, a support framethat can be coupled to the valve anchor, and an engagement mechanism forreleasable engaging the valve anchor. In the configuration of thedelivery system 100, the valve anchor and support frame are delivered toa target location in a collapsed configuration serially (orlongitudinally spaced relative to each other), rather thanconcentrically positioned relative to one another, thereby minimizingthe outer profile or diameter of valve prosthesis and that of deliverysystem during delivery.

Various embodiments will now be described more fully hereinafter. Suchembodiments may, however, be embodied in many different forms and shouldnot be construed as limited to the embodiments set forth herein; rather,these embodiments are provided so that this disclosure will be thoroughand complete, and will fully convey its scope to those skilled in theart. Thus, one or more features shown or otherwise disclosed in anembodiment herein may be interchangeably used or incorporated intoanother embodiment that may not expressly show or disclose suchfeature(s). Further, one or more features shown or otherwise disclosedfor an embodiment herein may be excluded from such embodiment, unlessexpressly indicated, using skill in the art.

The valve prosthesis delivery system described herein thus facilitatesdelivery of a valve prosthesis to the heart while minimizing trauma ordamage to the vessels and tissues of a patient. The various embodimentsdescribed herein provide a means for both pushing and pulling the valveprosthesis delivery system through the tight turns presented by theheart chambers. It is noted that for the purposes of describing thedisclosed systems and methods, the term “proximal” refers to a relativeposition closer to a control unit whereas the term “distal” refers to arelative position further away from a control unit.

FIG. 2 illustrates a valve prosthesis delivery system 100 that cansupport and deliver a valve prosthesis 105. As shown, the valveprosthesis 105 can comprise a support frame 107 and a valve anchor 120.In accordance with some embodiments, the delivery system 100 may includea core member 110 and an engagement mechanism 115 that can be configuredfor releasably engaging the valve anchor 120 relative to the core member110. Further, the delivery system 100 can also comprise a sheath 150that can extend distally to cover the support frame 107 and the valveanchor 120. The sheath 150 can maintain the support frame 107 and thevalve anchor 120 in a compressed configuration during delivery of thesystem 100 to the target location. When positioned at the targetlocation, the clinician can proximally retract the sheath 150 in orderto permit the support frame 107 to begin expanding. Thereafter,additional actuation of the engagement mechanism 115 and furtherproximal retraction of the sheath 150 can enable a clinician to releasethe valve prosthesis 105 at the target location.

In some embodiments, the engagement mechanism 115 may include a pinassembly 125 slidably coupled to the core member 110 and a lockcomponent 140. Together, the pin assembly 125 and the lock component 140can engage one or more structures of the valve anchor 120 and, whenreleased by the clinician, can disengage from the valve anchor 120 topermit the valve anchor 120 to fully expand or be released at the targetlocation. In this manner, the clinician can precisely control therelease of the valve anchor 120 from the delivery system 100.

As illustrated in FIG. 2, the valve anchor 120 may be positionedserially with a support frame 107 of the valve prosthesis 105. Both thesupport frame 107 and the valve anchor 120 can be made from a shapememory material such that they can be compressed to a radius whichallows delivery through, for example, arteries and veins, then expandedas needed for expansion and placement of the valve prosthesis 105 in adesired position.

Thus, although the support frame 107 and/or the valve anchor 120 canoptionally be balloon-expandable or be further expandable using aballoon, the embodiment illustrated in FIG. 2 is configured such thatthe support frame 107 or the valve anchor 120 self-expand when thesheath 150 is proximally retracted to position in which the sheath 150does not longitudinally overlap the respective one of the frame 107 orthe valve anchor 120.

For example, the support frame 107 and/or the valve anchor 120 cancomprise a braided frame, a wire frame, or a laser-cut frame, as shownin FIG. 2. In some embodiments, the support frame 107 and/or the valveanchor 120 can comprise a shape-memory metal, which can change shape ata designated temperature or temperature range or by inducing stress.Alternatively, the self-expanding frames can include those having aspring-bias. The material from which either the support frame 107 and/orthe valve anchor 120 is fabricated can allow the support frame 107and/or the valve anchor 120 to automatically expand to its functionalsize and shape when deployed but also allows the support frame 107and/or the valve anchor 120 to be radially compressed to a smallerprofile for delivery through the patient's vasculature. Examples ofsuitable materials for self-expanding components described herein (e.g.,support frames, valve anchors, locking members) include, but are notlimited to, medical grade stainless steel, titanium, nickel titaniumalloys, tantalum, platinum alloys, niobium alloys, cobalt alloys,alginate, or combinations thereof. Shape memory alloys havingsuperelastic properties generally made from ratios of nickel andtitanium, commonly known as nitinol, are preferred materials. In someembodiments, self-expanding components described herein can includematerials including, but not limited to shape memory plastics, polymers,and thermoplastic materials, which are inert in the body. In analternative embodiment, either the support frame 107 and/or the valveanchor 120 is not self-expanding, and may be expanded, for example,using a balloon catheter as is well known in the art.

In some embodiments, the valve anchor 120 may be movably coupled to thesupport frame 107 such that the valve anchor 120 may be moved from aconcentric position with the support frame 107 to a proximal or distalposition from the support frame 107. During delivery of the valveprosthesis 105, it is advantageous to have the valve anchor 120positioned serially from the support frame 107. This permits the radiusof the system to be minimized, thus enabling the system to be advancedthrough small diameter vessels, for example, arteries, and veins. Thedistance from which the valve anchor 120 may be serially displaced fromthe support frame 107 is variable, such that the valve anchor 120 may beadjacent to the support frame 107, or potentially inches away from thesupport frame 107 during the delivery procedure. In some embodiments,the valve anchor 120 is physically fixed to the support frame, such asby welding or otherwise adhering.

The delivery system 100 can be configured such that components of theheart valve prosthesis to be advanced in series while still beingmovably connected, movably attached, flexibly connected, displaceablyconnected, linked, or coupled to each other, thereby minimizing apassing profile or cross section of the delivery system. Theinterconnection of components of the heart valve prosthesis can allowdifferent degrees of motion and can be set into an engaged or retainedposition that provides a limited range of motion. In some embodiments,the engaged position can also provide a preset relative positioning ofthe components of the heart valve prosthesis to facilitate properplacement and release of the heart valve prosthesis. Additionally, someembodiments can provide a clinician with a high degree of control andenhance the maneuverability of the heart valve prosthesis whenimplanting the heart valve prosthesis at the target location.

In some embodiments, the valve anchor 120 can be coupled to the supportframe 107 when the support frame 107 is in the compact configurationprior to delivery and expansion. In some embodiments, the valve anchor120 is not fixed to the support frame 107. Further, the valve anchor 120can be separate from the support frame 107 or formed separately from andlater coupled to the support frame 107. Thus, although a least a portionof the valve anchor, e.g., the anchoring leg, may be in contact with orotherwise reversibly attached or connected to the support frame, no partof the valve anchor is fixed, e.g., welded or otherwise irreversiblyadhered, to the support frame. Alternatively stated, the valve anchor,which may be in contact with or otherwise reversibly attached to thesupport frame, is not irreversibly fixed to the support frame.

Further, upon reaching the target location, the valve anchor 120 can bemovably coupled to the support frame 107 in a manner that prevents theentire valve anchor 120 from being radially displaced from the supportframe 107 when the valve anchor 120 is initially expanded. For example,portions of the valve anchor 120 can be radially displaced from thesupport frame during initial “landing” of the valve anchor 120 againstthe native valve structure at the target location. In some embodiments,the support frame 107 can be deployed or expanded within the nativeheart valve structure, and the valve anchor 120 can become sandwichedbetween the support frame and the native valve tissue, becoming at leastpartially, and possibly fully, immobilized (as shown, for example, inFIGS. 7E and 7F). The valve anchor 120 can function to hold the expandedsupport frame 107 in place within the native valve structure.

In some embodiments, the valve anchor 120 can comprise at least oneU-shaped member, anchoring member, valve clasper, sinus locator, valvepositioner, or valve hanger 126 and at least one anchoring leg 122. TheU-shaped member 126 and the anchoring leg 122 can extend along alongitudinal axis of the valve anchor 120. As illustrated in FIG. 2, thevalve anchor 120 can comprise a plurality of U-shaped members 126, suchas three U-shaped members 126, but can have fewer or more.

The U-shaped members 126 can be coupled to the anchoring legs 122 atpeak portions or apices 128 of the valve anchor 120. Further, adjacentU-shaped members 126 can be coupled to each other at a respective apex128. The U-shaped members 126 can each comprise first and second legs146, 148 that meet or join at a base portion 144 thereof. The baseportions 144 of the U-shaped members 126 can be configured to engagewith or fit inside the posterior aortic sinus, the left aortic sinus,and the right aortic sinus of a native aortic valve. The first andsecond legs 146, 148 of the adjacent U-shaped members 126 can beinterconnected at the peak portions 128 thereof.

Referring now to FIGS. 2 and 6A-6F, the valve anchor 120 may include atleast one anchoring leg 122. The anchoring leg 122 can include acoupling portion 124 having a connector or connection aperture 127. Theconnector can comprise structures, such as slots or holes extendingthrough the coupling portion 124.

In some embodiments, the anchoring leg 122 of the valve anchor 120 ispositioned approximately parallel relative to the longitudinal axis ofthe support frame 107 and is attached to U-shaped member 126 at an apex128. As used herein, the apex 128 may be a vertex where the U-shapedmember(s) 126 joins with the anchoring leg 122. In some embodiments, twoU-shaped members 126 may curve to join the anchoring leg 122 at thevertex or apex 128. In some embodiments, the vertices of the valveanchor 120 may be configured such that two anchoring legs 122 extendapproximately parallel relative to each other. In some embodiments, thevalve anchor 120 includes at least two U-shaped members 126 and twoanchoring legs 122.

Each of the first or proximal ends of the two anchoring legs 122 arejoined to the U-shaped member 126. In additional embodiments, asillustrated in FIG. 2, the second or distal end of one or more of theanchoring legs 122 terminates in a coupling portion 124. That is, thecoupling portion 124 of the valve anchor 120 is positioned at an endportion of the valve anchor anchoring leg 122. The coupling portion 124may be made of a shape memory alloy such as nitinol. For someapplications, the coupling portion 124 may be oriented parallel relativeto a longitudinal axis of the valve prosthesis 105, while for otherapplications, the coupling portion 124 may be oriented to form an anglewith respect to the longitudinal axis.

For example, the coupling portion 124 may be approximately parallelrelative to the longitudinal axis of the support frame 107 in thecompact position and/or when the valve prosthesis 105 is encased in asheath 150. Alternatively, as illustrated in FIG. 2, the couplingportion 124 may form an angle with respect to the longitudinal axis ofthe valve prosthesis 105 or the anchoring leg 122 when the valveprosthesis 105 is in an expanded condition. The detents can help tosecure the valve anchor 120 to the support frame 107 after the valveprosthesis 105 is expanded in the native valve.

It will be appreciated by those with skill in the art that the shape ofthe base portion 144 joining the two anchoring legs 122 of the U-shapedmember 126 is not limited to being a U-shaped or rounded. The baseportion 144 may have other shapes including, but not limited to,rectangle, square, diamond, triangle, oval, circle, or a combination ofthese shapes. The base portion 144 may be of any shape that allows it toengage and/or rest adjacent to the commissure of the native valveleaflets 190.

In some embodiments, the valve anchor 120 may comprise a plurality ofU-shaped members 126 coupled to the support frame 107. That is, thedelivery system 100 may include, but is not limited to, two, three,four, five, or more plurality of U-shaped members 126, to accommodatedifferent valve replacement procedures or according to the anatomicalstructure of the native valve that is to be replaced. In the variousembodiments disclosed in the figures, the number of plurality ofU-shaped members 126 in the valve prosthesis is three.

Additionally, in accordance with some embodiments, the valve prosthesis105 can be configured such that the support frame 107 is coupled to thevalve anchor 120. For example, the valve prosthesis 105 can comprise atleast one suture 170 that couples the support frame 107 to the valveanchor. In some embodiments, a distal end portion of the support frame107 can be coupled to the valve anchor 120 via the suture 170. Theportion of the suture 170 that attaches to the valve anchor 120 can becoupled to and anchoring leg 122 of the valve anchor 120. In accordancewith some embodiments, the anchoring leg 122 can comprise a longitudinalslot 123 that extends along the length of the anchoring leg. The suture170 can loop into the slot 123 and be coupled with the anchoring leg122. This can enable the suture 170 to slide along the length of theslot 123 during expansion of the valve prosthesis 105, as discussedfurther herein.

FIGS. 3A and 3B are illustrations of perspective and cross-sectionalviews of an embodiment of a nose cone 156 of the valve anchor deliverysystem 100 of FIG. 2. As illustrated in FIGS. 2, 3A, and 3B, thedelivery system 100 may include a nose cone 156 at a distal end thereof.The nose cone 156 may have a substantially tubular and/or conicalprofile that tapers towards a distal end of the nose cone 156. Further,the nose cone 156 can comprise a lock component 140 and a cavity 141. Insome embodiments, the nose cone 156 can interact as part of theengagement mechanism 115, to permit the lock component 140 and the pinassembly 125 to engage the valve anchor 120.

In accordance with some embodiments, the nose cone 156 may be configuredto be coupled to or mate with a distal end of the valve sheath 150 inorder to reduce any seam along the outer surface of the delivery system100 between the nose cone 156 and the sheath 150. The mating engagementbetween the nose cone 156 and the sheath 150 can thereby provide asmooth, continuous outer surface of the delivery system 100.

For example, the nose cone 156 may include a radial depression 154against which the distal end of the valve sheath 150 can be positionedin a delivery configuration. The radial depression 154 can permit atleast a portion of the nose cone 156, including the lock component 140,to be inserted into a lumen 152 of the valve sheath 150 to detachablycouple the nose cone 156 to the valve sheath 150. Although the radialdepression 154 is illustrated as having a generally conical profile, theradial depression 154 can also comprise a stepped profile in which theouter diameter of the nose cone 156 steps down from a diameterapproximately equal to an outer diameter of the sheath 150 to a diameterthat is approximately equal to an inner diameter of the sheath 150. Inthis manner, the nose cone 156 can fit inside of the sheath lumen andengage with the sheath 150 while both having a common or approximatelyequal outer diameter.

In some embodiments, the lock component 140 can be integrally formedwith nose cone 156. However, in some embodiments, as illustrated inFIGS. 3A and 3B, the nose cone 156 can be an assembly of components,including a distal cone component 157 and the lock component 140. Thelock component 140 can comprise an aperture 158 through which the pinassembly may be engaged or moved by the pusher component, as discussedbelow.

For example, as illustrated in FIG. 3B, a proximal end portion of thedistal cone component 157 can be coupled with a distal end portion ofthe lock component 140 by welding, frictional engagement, or otheradhesive means. Further, the distal cone component 157 and the lockcomponent 140 can collectively form the cavity 141. In some embodiments,both the distal cone component 157 and the lock component 140 cancomprise inner cavities that combined to form the cavity 141 when thedistal cone component 157 and the lock component 140 are coupledtogether. As discussed further herein, the cavity 141 can provide avolume in which the pin assembly 125 of the engagement mechanism canreciprocate.

The nose cone 156 may further include a channel or passageway 155extending centrally along a longitudinal axis of the nose cone. Thechannel 155 may be configured to receive the core member 110 as the coremember reciprocates proximally and distally along the longitudinal axisin order to cause a corresponding motion of the support frame 107 andthe valve anchor 120.

In accordance with some embodiments, the lock component 140 may includeat least one lock aperture 145. The lock aperture 145 may be disposedproximal to the cavity 141. In some embodiments, the pin assembly 125can include a plurality of pins 135, and the lock component 140 caninclude a plurality of lock apertures 145, each corresponding to one ofthe plurality of pins 135.

Further, as illustrated, the lock component 140 can comprise anengagement region 143 interposed between a proximal flange 147 and adistal flange 149. The lock aperture 145 can extend through both theproximal flange 147 and the distal flange 149. The lock aperture 145that extends through the distal flange 149 can extend into the cavity141. Accordingly, a pin extending from the pin assembly 125 can passthrough the distal flange 149, extend across the engagement region 143,and pass through the proximal flange 147. Thus, as illustrated anddiscussed further herein, a pin of the pin assembly 125 can be radiallyconstrained by the lock aperture 145 extending through the distal flange149 and the proximal flange 147 and engage with a portion of the valveanchor 120 that extends into the engagement region 143.

For example, as illustrated in FIGS. 6A-6F, the pin assembly 125 canreciprocate within the cavity 141 between an engaged configuration(shown in FIGS. 6A-6C) and a disengaged configuration (shown in FIGS.6D-6F). When the pin assembly 125 moves from the engaged configurationto the disengaged configuration, pins 135 of the pin assembly 125 canslide out of engagement with the lock apertures 145 of the lockcomponent 140. As such, the pins 135 can be distally advanced out of theengagement region 143 and received into the cavity 141 and the distalflange 149, thus disengaging with valve anchor 120 and permitting thevalve anchor 120 to expand out of the engagement region 143.

As illustrated in FIGS. 6A-6C, the pin assembly 125 and the lockcomponent 140 can engage the valve anchor 120 in an engagedconfiguration. Thus, after the sheath 150 has been proximally withdrawnto permit U-shaped members of the valve anchor 120 to expand radially,the valve anchor 120 remains engaged with the delivery system 100,thereby permitting the clinician to rotate, repositioning, or otherwisemaneuver the U-shaped members of the valve anchor 120 into a desiredposition relative to the native valve structure.

FIGS. 4A and 4B illustrate a pin assembly 125 and an alternative pinassembly 125′, either of which can be used with the delivery system 100of FIG. 2, according to some embodiments. As illustrated in theembodiment shown in FIG. 4A, the pin assembly 125 may comprise a tubularcomponent 130 having a proximal section 132 and a distal section 134.Further, both pin assemblies 125, 125′ can comprise an annularcomponent, such as a piston member 136, and at least one pin 135 coupledto the annular component or piston member 136. The annular component canhave the shape of a disc, a cylinder, a torus, or others that can becoupled to and at least partially surround the core member 110. The pinassembly 125 can also be configured such that the distal section 134 ofthe tubular component 130 is coupled to the piston member 136. Thealternative pin assembly 125′ can be identical to the pin assembly 125of FIG. 4A in all respects except for the absence of the tubularcomponent 130.

The pin assemblies 125, 125′ can slide along the core member 110 of thedelivery system 100. For example, the core member 110 can be configuredto extend through the lumen 133 of the pin assembly 125. The lumen 133can extend through both the tubular component 130 and the piston member136.

An advantage of the pin assembly 125 may lie in the presence of thetubular component 130, which can assist in maintaining axial alignmentof the piston member 136 and the pins 135 relative to the longitudinalaxis of the delivery system 100 during use. However, in eitherembodiment of the pin assembly, the longitudinal extent of the lumen 133through the piston member 136 can be of a sufficient length in order toprevent misalignment or wobbling of the piston member 136 relative tothe core member 110. Accordingly, both pin assemblies 125, 125′ canadvantageously maintain the pins 135 in an alignment that isapproximately parallel relative to the core member 110. In this manner,the pins 135 can slide smoothly out of engagement with the lockapertures 145 of the lock component 140. Further, proximal ends of thepins 135 can be advanced distally through the engagement region 143sufficiently to permit the valve anchor 120 to disengage therefrom.Thus, in some embodiments, although the pins 135 may continue to extendinto the engagement region 143, the valve anchor 120 may be able todisengage therefrom. However, in some embodiments, the proximal ends ofthe pins 135 may be fully received into the lock apertures 145 such thatthe pins 135 do not extend into the engagement region 143 in thedisengaged configuration.

Although only one or two pins 135 may be used, the illustratedembodiments provide for three pins 135 to be used. The pins 135 extendproximally from the piston member 136 and can be radially spaced apartfrom the tubular component 130.

Optionally, in some embodiments, the piston member 136 can comprise twoplates or discs that are coupled to each other. In such embodiments, thepins 135 may be positioned to extend through a proximal plate withdistal end portions of the pins 135 being sandwiched between theproximal plate and a distal plate of the piston member 136, therebyengaging the distal end portions of the pins 135 therebetween.

For example, the distal end portions of the pins 135 may be bent atangles, as illustrated in FIGS. 6A-6F, and at least one of the twopiston members 136 may have a groove formed therein to accommodate andhold the bent distal end portions of the pins 135 in a fixed positionwith respect to the pin assembly 125 when the proximal and distal platesof the piston member 136 are coupled together. Alternatively, however,the pins can be welded, mechanically fastened, or otherwise adhesivelycoupled to the piston member 136. Accordingly, the piston member 136 andthe pins 135 can slide along the core member 110 as a unit betweenengaged and disengaged positions, as discussed herein.

FIGS. 5A and 5B illustrate a pusher component 165 and an alternativepusher component 165′, either of which can be used with the deliverysystem 100 of FIG. 2, according to some embodiments. In someembodiments, the pusher component 165 can be used in combination withthe pin assembly 125, shown in FIG. 4A.

The pusher component 165′ can be used in combination with the pinassembly 125′, shown in FIG. 4B. In the embodiment shown, whereas thepusher component 165 does not include an elongate shaft component thatcontacts against the pin assembly 125, the pusher component 165′ mayvary from the pusher component 165 by including a shaft component 167that can extend through the aperture 158 of the lock component 140 ofthe nose cone 156. When used with the pin assembly 125′, the shaftcomponent 167 of the pusher component 165′ can extend through or intothe aperture 158 to facilitate movement and disengagement of the pinassembly 125′. However, these components 125, 125′, 165, 165′ can beinterchanged or modified in any of the embodiments disclosed herein.Thus, in some embodiments, the pusher component 165 can be contactedagainst the tubular component 130 of the pusher component 165 extendingthrough the aperture 158 of the lock component 140. However, in someembodiments, the shaft component 167 of the pusher component 165′ canextend through the aperture 158 of the lock component 140 to contactagainst the pin assembly 125′.

As illustrated in FIGS. 5A and 5B, the pusher component 165 and thepusher component 165′ may each comprise a lumen 166 through which thecore member 110 can pass, thereby permitting the pusher component 165and the pusher component 165′ to be slidably disposed along the coremember 110. As illustrated in the system views of FIGS. 6A-6F, thepusher component 165 (whether the pusher component 165 and the pushercomponent 165′) can be disposed distally relative to the support frame107. Eventually, as discussed below, the pusher component 165 can becontacted against the tubular component 130 of the pusher component 165,which extends through the aperture 158 of the lock component 140.

In accordance with some embodiments, the pusher component 165 can havean outer diameter or profile that is about equal to a compresseddiameter of the support frame 107. Thus, the pusher component 165 andthe support frame 107 can be received within the lumen of the sheath150. Further, the distal end portion of the support frame 107 can abutor contact a proximal face 172 of the pusher component 165. As discussedfurther herein, some embodiments can permit the support frame 107 to bepressed distally against the proximal face 172 of the pusher component165 in order to exert a distally directed force against the pushercomponent 165, which can then cause the pusher component 165 to contactthe pin assembly 125 and cause disengagement of the pins 135 from thevalve anchor 120.

In some embodiments, the pusher component 165 comprises a flange 175. Asillustrated in FIG. 5A, the flange 175 may be a radial flange thatdefines the proximal face 172. Further, the pusher component 165 cancomprise a distal face 174 having a generally sloped or conical profile.The conical profile of the distal face 174 can tend to allow the pushercomponent 165 to avoid catching or otherwise engaging with the valveanchor 120 during distal advancement of the pusher component through thevalve anchor 120, as discussed below.

Although various mechanisms can be employed, in some embodiments, distaladvancement of the pusher component 165 can be achieved by contactingthe distal end of the support frame 107 against the proximal face 172 ofthe pusher component 165. For example, with reference to FIG. 6A, thedelivery system 100 can comprise a pushing block 178 that is coupled toa pusher tube 179. The pusher tube 179 and the pushing block 178 caneach comprise lumens through which the core member 110 can pass. Thepusher tube 179 and the pushing block 178 can be slidably positionedalong the core member 110. During the procedure, once the sheath 150 hasbeen proximally retracted to a position approximately shown in FIG. 6B,the pusher tube 179 and the pushing block 178 can be distally advancedby the clinician along with the sheath 150, which can exert a distalforce against the support frame 107 and the pusher component 165. Thisdistally oriented force can urge the pusher component 165 toward aproximal contact face or area 137 of the pin assembly 125, 125′, shownillustratively by the movement depicted from FIGS. 6B to 6C.

Accordingly, in some embodiments, the distal face 174 of the pushercomponent 165, 165′ can contact the proximal contact face 137 of the pinassembly 125, 125′ and urge the pin assembly 125, 125′ in a distaldirection relative to the lock component 140. In some embodiments, thetubular section can be coupled to either the pusher component or the pinassembly or to both. Movement of the pin assembly 125, 125′ in thedistal direction results in shifting of the engagement mechanism 115from the engaged configuration (shown in FIG. 6C) to the releasedconfiguration (shown in FIG. 6D).

Accordance with some embodiments, the pusher tube 179 and the pushingblock 178 can be actuated via a control unit (not shown) that can beoperated by the clinician. The control unit can be communicativelycoupled to the core member 110 and to the pusher tube 179 to allow theclinician to actuate or move the core member 110 relative to the pushertube 179. In this manner, the pusher tube 179 can be distally advancedover the core member 110 in order to cause the pusher component 165 tocontact the pin assembly 125 and cause the pin assembly 125 to movewithin the cavity 141 of the nose cone 156, thereby distally advancingthe pins 135 through the engagement region 143.

In some embodiments, the control unit can be communicatively coupled tothe pusher component 165 to selectively actuate the pusher component 165without requiring interaction from the pusher block 178 and the supportframe 107. For example, the pusher component 165 can be directly coupledto the pusher tube 179 in order to directly actuate the pusher component165 to contact and urge the pin assembly 125 in the distal directionrelative to the lock component 140. Similar to the embodimentillustrated in figures, such an embodiment can move the engagementmechanism 115 from the engaged configuration to the releasedconfiguration.

In some embodiments, the lumen 166 of the pusher component 165 can havean inner diameter that is smaller than an inner diameter of the tubularcomponent 130 or the lumen 133 of the pin assembly 125. Such embodimentscan thus allow the pusher component 165 to have a sufficientcross-sectional profile to allow the pusher component 165 to advancedistally and contact and eventually urge or push the pin assembly 125distally.

FIGS. 6A-6C illustrate the valve anchor 120 of the delivery system 100in the engaged configuration. When the legs 122 of the valve anchor 120are inserted into the engagement region 143 and locked in place via theengagement mechanism 115, this is referred to the engaged configuration(see FIGS. 6A-6C). In the engaged configuration, the pins 135 arepositioned extending from the cavity 141 of the nose cone 156, throughthe connection aperture 126 of the valve anchor leg 122, and into andthrough the lock apertures 145 of the lock component 140 of nose cone156. As such, in the engaged configuration, the at least one leg 122 ofthe valve anchor 120 is locked in engagement at a position between thelock component 140 of the nose cone 156 and the rest of the nose cone156.

Further, FIG. 6A illustrates the valve prosthesis 105 and the valveanchor 120 housed in a compact state within the sheath 150 of thedelivery system 100, according to some embodiments. When the deliverysystem 100 is initially introduced into the target location of thedefective valve, the delivery system 100 is delivered in the compactstate, as illustrated in FIG. 6A.

FIG. 6B illustrates the valve anchor 120 in an engaged configuration,but released from the sheath 150 of the delivery system 100 of FIG. 2,according to some embodiments. Once the delivery system 100 nears thetarget location, the sheath 150 of the delivery system 100 is proximallyretracted relative to the core member 110 via, for example, a controlunit including at least one controller or processor. Retraction of thesheath 150 from over the valve anchor 120 allows the valve anchor 120 toexpand radially. The U-shaped members 126 can thereafter be guided andmaneuvered into a desired position relative to the surrounding nativevalve structure, as discussed herein.

After the U-shaped members 126 are in a desired position relative to thesurrounding native valve structure, the remainder of the valve anchor120 can be released. FIG. 6C illustrates the first step and releasingthe valve anchor 120. As shown, in some embodiments, the pusher block178, the sheath 150, and the support frame 107 can be urged in a distaldirection, thereby distally advancing the pusher component 165 towardsthe pin assembly 125 of the delivery system 100. This distal movement ofthe pusher component 165 into the lumen of the valve anchor 120 ispossible because the valve anchor 120 has already expanded radially,despite being locked in the engaged configuration by the engagementmechanism 115. In the partially expanded position illustrated in FIG.6C, the at least one U-shaped member 126 of the valve anchor 120 mayextend radially from the anchoring leg 122 of the valve anchor 120 andthe longitudinal axis of support frame 107.

As also illustrated in FIG. 6C, in the engaged configuration, thetubular component distal section 134 or a proximal surface of the pistonmember 136 is axially spaced apart from a proximal surface of the lockcomponent 140 at a first distance D1. The first distance D1 issufficient to permit the pins 135 to extend from the cavity 141 throughthe lock apertures 145 and the engagement region 143; as such, the pins135 can extend through the leg connection aperture 127 of the valveanchor 120 and the lock component lock aperture 145 to interconnect thevalve anchor anchoring leg 122 with the engagement mechanism 115. Forexample, the first distance D1 may be between about 1 mm and about 20mm, between about 2 mm and about 15 mm, between about 4 mm and about 12mm, between about 6 mm and about 10 mm, between about 8 mm and about 10mm, or about 2 mm, about 2 mm, about 4 mm, about 6 mm, about 8 mm, about10 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm, about 20 mm,about 22 mm, about 24 mm, about 26 mm, about 28 mm, about 30 mm, about35 mm, or about 40 mm.

As the pusher component 165 is urged distally, the pusher componentcontacts the pin assembly 125 and begins to urge the pin assembly 125distally through the cavity 141. As this happens, the pins 135 slidedistally through the engagement region 143, eventually permitting theanchoring legs 122 to disengage from the pins 135 and permitting thevalve anchor 120 to assume a released configuration. FIG. 6D is anillustration of the valve anchor 120 in a released configuration.

Referring still to FIG. 6D, in the released configuration, the tubularcomponent distal section 134 or the proximal surface of the pistonmember 136 can be axially spaced apart from the proximal surface of thelock component 140 at a second distance D2, which is greater than thefirst distance D1. The second distance D2 is sufficient to position thepins 135 outside of the lock aperture 145 to permit the valve anchor leg122 to disengage from the pins 135 of the pin assembly 135. For example,the second distance D2 may be between about 1 mm and about 20 mm,between about 2 mm and about 15 mm, between about 4 mm and about 12 mm,between about 6 mm and about 10 mm, between about 8 mm and about 10 mm,or about 2 mm, about 2 mm, about 4 mm, about 6 mm, about 8 mm, about 10mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm, about 20 mm,about 22 mm, about 24 mm, about 26 mm, about 28 mm, about 30 mm, about35 mm, or about 40 mm.

In operation, as the pin assembly 125 is advanced distally, the pins 135are displaced a distance corresponding to the difference between D2 andD1, thereby releasing the valve anchor 120 from engagement with the pinassembly 125, and allowing the valve anchor 120 to radially expand inpreparation for positioning the support frame 107 therewithin.

As illustrated in FIG. 6D, after the valve anchor 120 has been releasedfrom the delivery system 100, the support frame 107 continues to behoused within the sheath 150 of the delivery system 100. However, afterthe longitudinal or axial position of the support frame 107 has beenadjusted to be centered or otherwise properly positioned within thelumen of the valve anchor 120, the clinician can thereafter initiaterelease and expansion of the support frame 107 within the lumen of thevalve anchor 120. As part of this adjustment for positioning process,the clinician may distally advance the support frame 107. In someimplementations of the method, the clinician may advance the supportframe 107 to a position longitudinally distal to the valve anchor 120and thereafter proximally retract the support frame 107. Such a motionmay ensure that the native valve leaflets are drawn upwardly between aspace between the valve anchor 120 and the support frame 107.Thereafter, the expansion and release of the support frame 107 can beinitiated by the clinician, as discussed further below.

Expansion and release of the support frame 107 can be initiated, asillustrated in FIG. 6E. FIG. 6E illustrates the sheath 150 beingproximally retracted to expose and permit initial expansion of thesupport frame 107. FIG. 6F illustrates the sheath 150 being furtherretracted to permit the support frame 107 to be fully expanded withinthe valve anchor 120. In some embodiments, further retraction of thesheath 150 causes the valve prosthesis 105 to be completely exposed,thereby allowing the valve prosthesis to expand radially within thevalve anchor 120. However, in some embodiments, the outward force of theself-expanding support frame 107 can cause the support frame 107 tospring open after the sheath 150 has been partially proximally withdrawn(i.e., reaching a position distal to that illustrated in FIG. 6F).

Methods for Operating and Manufacturing a Valve Prosthesis DeliverySystem

Methods for implanting an aortic valve prosthesis using the deliverysystem described herein involve non-surgical delivery and implantationof an aortic valve prosthesis wherein a self-expandable implant withprosthetic leaflets is flexibly coupled to a valve anchor, and whereinthe support frame and the valve anchor are delivered in a compactcondition.

Regardless of the route of administration or access, delivery systemsdisclosed herein can be operated to release the valve anchor prior toexpansion of the support frame. Moreover, the valve anchor may bemanipulated and re-positioned after expansion to ensure proper placementbefore expanding or releasing the support frame. Optionally, the systemcan be operated using any of a variety of imaging techniques, includingultrasound, fluoroscopy, or pulsatile feedback, such as electric pulsesor ultrasound pulses. Thus, the valve anchor can be positioned usingimaging techniques, if desired.

In some embodiments, the clinician can determine or feel, via tactilepressure, that valve anchor has been properly seated or engaged with thenative valve structure to confirm proper positioning of the valve anchorrelative to the native valve structure. After proper placement of thevalve anchor, the support frame can be moved distally along thelongitudinal axis toward the valve anchor had eventually be positionedapproximately concentric with the valve anchor. At this time, thesupport frame may be released, and the delivery system can be removedfrom the patient. The support frame can be implanted over the existingnative valve leaflets.

FIGS. 7A-7F illustrate a method for operating a valve prosthesisdelivery system. The delivery system can be advances through the aortato the native aortic valve using a delivery system, such as theembodiment described above in FIGS. 6A-6F. As shown in FIG. 7A, in someembodiments, a guiding mechanism, e.g., a guidewire 180 may be advancedtowards the target location and fed through the core member 110 topermit the delivery system 100 to advance toward the target locationalong the guidewire 180. Entry of the delivery system 100 into thevasculature can occur through a variety of paths. However, as describedin the present disclosure, the guidewire 180 can be introduced into theaorta and advanced towards the aortic arch. The delivery system 100 canthen be advanced along the guide wire 180 until reaching the targetlocation, e.g., the aortic valve of the heart.

FIG. 7A illustrates the delivery system 100 after reaching the aorticvalve. As discussed above with regard to FIGS. 6A-6F, the deliverysystem 100 can be delivered to the target location a deliveryconfiguration (FIG. 6A) and later manipulated to permit expansion ofvarious components of the valve prosthesis 105.

As described above, FIG. 6A illustrates the delivery system 100 as it isconfigured prior to inserting the delivery system into the patient andduring advancement of the delivery system through the patient'svasculature toward the target location. The valve prosthesis 105 ispacked within the delivery system 100 in a compact configuration suchthat the support frame 107 and the valve anchor 120 of the valveprosthesis 105 are packed serially within the sheath 150. As is normalpractice, the guidewire is first introduced into the patient, e.g., intothe femoral artery or, if using a transapical procedure, into the leftventricle, and advanced to the appropriate heart chamber, past or beyondthe native cardiac valve in need of repair. Although not illustrated inthe figures, the present disclosure can also provide for transapicaldelivery of the valve prosthesis 105.

A method of delivering a valve prosthesis to a target location having adamaged or defective valve includes advancing the delivery system 100into a blood vessel, e.g., the aorta, to position the valve anchor 120at the target location. In some embodiments, the target location is aposition adjacent to an aortic valve of a patient's heart. Inparticular, the target location may be a position directly above thenative aortic leaflets 190, as illustrated in FIG. 7A. The advancing ofthe delivery system 100 may be achieved by advancing a distal endthereof to the target location in a direction opposite to that of bloodflow.

Once the delivery system has been advanced into the blood vessel, theclinician can control the delivery system 100 by actuating one or moreactuators on the control unit. In some embodiments, the actuator(s) maybe, but is not limited to a knob, a lever, a trigger, a slider, abutton, and/or a handle of the control unit. Actuation of the actuatorcan cause the sheath 150 to retract proximally and reveal at least aportion of the valve anchor 120 at the target location (as shown inFIGS. 6A to 6B and 7A). Proximal retraction of the sheath 150 permitsthe U-shaped members 126 of the valve anchor 120 to expand at the targetlocation for positioning the valve anchor 120 in a desired orientation.As portions of the U-shaped member 126 are exposed, they will tend toexpand radially away from the central axis (or guidewire axis). Theradial extension of the U-shaped members 126 can permit the clinician toat least initially align, position, and/or rotate the delivery system100 into proper alignment within the native valve. In some situations,advancement of the delivery system 100 through the native vasculaturecan tend to cause the U-shaped member to bend backwards or evert in adirection opposite that shown in FIG. 7A. In such situations, if thesheath 150 is retracted only partially from over the valve anchor 120,the sheath 150 can be distally advanced relative to the valve anchor 120to push or urge the U-shaped members into a forward-pointing ornon-everted orientation, as shown in FIG. 7A.

FIG. 7A illustrates placement of the distal end of delivery system 100including the nose cone 156 within the aorta past the native aorticvalve. The distal end section of the delivery system 100, including thenose cone 156, can be advanced and positioned in the aorta past thenative aortic valve leaflets 190. As shown in FIGS. 7A and 7B, afterproperly positioning the valve sheath 150, which houses the valveprosthesis 105, within the aorta, the valve sheath 150 can be pulled ina proximal direction to uncover the valve anchor 120. This allows thebase portions 144 of the U-shaped members 126 of the valve anchor 120 toradially expand towards the interior wall of the aorta.

In some embodiments, as discussed herein, the base portions 144 of thevalve anchor 120 function as “feelers” which allow the clinician toproperly place the valve anchor 120 and support frame 107 within thenative valve structure with minimal or no imaging during the time ofexpansion (see FIGS. 7A and 7B). The valve anchor 120 may be made of,but not limited to, a shape memory material or metal, such as nitinol,as discussed herein.

In some embodiments, the delivery system 100 is further advanceddistally and/or rotates until the valve anchor 120 gently sits in thenative aortic structure, such as the annulus or sinuses, at the targetlocation. While the valve anchor 120 is advanced distally, it rotatesand can self-align according to the anatomical orientation of the nativeaortic leaflets 190, as shown in FIG. 7B.

After the valve anchor 120 is properly seated or positioned relative tothe native valve structure, the clinician can distally advance thepusher component 165 to contact and distally advance the pin assembly125 relative to the lock component 140. In some embodiments, the distaladvancement of the pusher component 165 comprises distally advancing thepusher block 178 to contact and displace the support frame 107 and thepusher component 165 in a distal direction until contacting the pinassembly 135. This causes an increase in the axial spacing between thelock component 140 and the piston member 136 (not shown), as illustratedby distances D1 and D2 in FIGS. 6C and 6D, thereby distally advancingthe pins 135 out of the engagement region 143.

Accordingly, as shown in FIGS. 7C and 7D, in some embodiments, thedistally advancement of the pusher component 165 comprises contactingand distally displacing the proximal face 172 of the radial flange 175(not shown, but see FIGS. 6B-6D) of the pusher component 165 relative tothe core member 110, by distally advancing the support frame 107 in thecollapsed state by advancing the pusher block 178 and the sheath 150relative to the core member 110. Distal advancement of the pin assembly125 relative to the lock component 140 causes the pins 135 of the pinassembly 125 to disengage from the lock aperture 145 of the lockcomponent, thereby permitting release of the valve anchor 120 from thedelivery system 100.

After releasing the anchoring legs 122 of the valve anchor 120 in orderto fully release the valve anchor 120, the delivery system 100 canoptionally be distally advanced within the valve anchor 120 in order toposition the support frame 107 at a desired longitudinal position withinthe lumen of the valve anchor 120. Thereafter, the valve sheath 150(which at this time, continues to extend over or cover the support frame107) can be retracted distally relative to the core member 110 towardsthe lock component 140, as illustrated in FIGS. 7E and 7F.

In accordance with some embodiments, the delivery system 100 can also beadvantageously configured to position portions of the valve anchor 120on opposing sides of the native valve leaflets. Such an ability enablesthe delivery system 100 to create a more secure engagement between thevalve anchor 120 and the native valve structure. Such configurations andadvantages can be achieved by using the engagement mechanism, which canconstrain a portion of the anchoring legs of the valve anchor. Further,other embodiments can also provide additional features that facilitateengagement of the opposing sides of the native valve leaflets.

For example, as illustrated in FIG. 7B, the support frame 107 can beslidably coupled to the anchoring leg 122 of the valve anchor 120 via asuture 170, which can create a radial restriction against expansion ofthe proximal portion of the valve anchor 120. When the support frame 107is moved distally towards the lock component 140, the suture 170 isaccordingly moved distally along the anchoring leg 122 of the valveanchor 120 toward the lock component 140 (see FIGS. 7B-7D). The reliefof the radial restriction created by the sutures 170 thereby permits theproximal end portion of the valve anchor 120 to expand radially outwardswhile holding distal ends of the valve anchor 120 stationary along alongitudinal axis thereof as the valve anchor 120 expands radially. Theanchoring legs 122 of the valve anchor 120 can thus be positionedradially inside of or central to the valve leaflets and the baseportions 144 of the U-shaped members 126 can be positioned directlyagainst the aortic wall (e.g., within the valve sinuses), radiallyoutside of or about the periphery of the valve leaflets.

Thereafter, the sheath 150 and the support frame 107 are thus advanceddistally until distal ends of the sheath 150 and the support frame 107are positioned directly above the lock component 140. FIG. 7Dillustrates a positioning of the support frame 107 in a final,pre-release position. The distal advancement of the sheath 150 and thesupport frame 107 to the position directly above the lock component 140also positions the support frame 107 at a pre-release position, whichcan be adjusted as needed after releasing the valve anchor 120. In someembodiments, the pre-release position is a position in which the supportframe 107 is disposed within the sheath 105 and longitudinally within apassage of the valve anchor 120.

When the support frame 107 reaches the final the pre-release position,the clinician can then further advance the pusher component 165 todistally advance the pin assembly 125 and thereby release the valveanchor 120 from engagement with the pin assembly 125. That is, theanchoring legs 122 can be released from being locked or engaged in theengagement region 143 between the lock apertures 145 of the lockcomponent 140 and the connection aperture 127 of the pin assembly 125,as illustrated in FIG. 7E.

FIG. 7E also illustrates the support frame 107 in a partially expandedconfiguration. After the anchoring legs 122 of the valve anchor 120 arereleased from being locked between the lock component 140 and the pinassembly 125, the control unit is then activated to retract the sheath150 proximally along the core member 110 to expose or reveal the supportframe 107 and permit the support frame 107 to begin to expand. As thesupport frame 107 begins to expand, the support frame 107 can becircumferentially constrained (i.e., the rotational orientation of thesupport frame 107) relative to the valve anchor 120 via the sutures 170.Thus, in some embodiments, the sutures 170 can cause expansion of thesupport frame 107 can be automatically guided and secured in the properposition by the valve anchor 120.

Referring now to FIG. 7F, the valve prosthesis 105 can comprise aplurality of prosthetic valve leaflets 109 coupled to the support frame107. The valve leaflets 109 can have surfaces that form a reversiblysealable opening for unidirectional flow of a liquid through the valveprosthesis 105. The valve prosthesis 105 can include three valveleaflets 109 for a tri-leaflet configuration. As appreciated,mono-leaflet, bi-leaflet, and/or multi-leaflet configurations are alsopossible.

For example, the valve leaflets 109 can be coupled to the support frame107 to span and control fluid flow through the lumen of the valveprosthesis 105. Further, in some embodiments, the valve prosthesis 105can comprise a membrane or sealing layer 108 that is coupled to thesupport frame 107 and the valve leaflets 109. The membrane 108 can tendto ensure that blood flows through the central aperture or lumen of thevalve prosthesis 105. The valve prostheses as described herein may beused in various aspects of implantation systems described herein or inany method or system known by one with ordinary skill in the art toimplant a valve prosthesis into a subject.

The sealing and anchoring of the valve prosthesis 105 relative to thesurrounding native valve structure is also facilitated through theinterposition of the native heart valve leaflets 190 between the valveanchor 120 and the support frame 107. This positioning of the valveleaflets 190 facilitates anchoring of the valve prosthesis 105 in thenative valve structure and can be applicable to all coronary valves(i.e., aortic, pulmonary, tricuspid and mitral). In some embodiments,the number of valve anchors 120 can be equal to the number of nativeleaflets 190 within the native valve being treated.

FIG. 7F illustrates the support frame 107 in the fully expanded,released configuration. As illustrated in FIG. 7F, the support frame 107may be properly placed within the native valve structure when the baseportions 144 of the U-shaped members 126 of the valve anchor 120 areapproximately adjacent to the distal end of support frame 107. Further,the support frame 107 may be properly placed within the native valvestructure when expansion of support frame 107 will result in asandwiching of the native aortic valve leaflets 190 between the expandedsupport frame 107 and valve anchor 120.

In some embodiments, after the support frame 107 has been expanded andreleased within the native valve structure, the control unit may beactuated to retract the rest of the delivery system 100, other than thesupport frame 107 and the valve anchor 120. For example, the sheath 150can be distally advanced over the core member 110 to mate the radialdepression 154 of the nose cone 156 against the distal end of the sheath150. In this manner, the delivery system 100 can assume the deliveryconfiguration in which the delivery system 100 has a generally smoothouter profile that will avoid catching or otherwise damaging thevasculature during removal. The delivery system 100 can thereafter beremoved from the patient.

Additional Aspects of Valve Prostheses

As also illustrated in FIG. 7F, when expanded and released, the supportframe 107 can comprise a first end portion 210 and a second end portion212. The first end portion 210 can be positioned upstream of the secondend portion 212 when the prosthesis 105 is released within the nativevalve structure.

As illustrated in FIG. 7F, the first end portion 210 of the supportframe 107 can be shaped as a generally flat end of a cylinder, wherefirst apices 214 of the support frame 107 lie generally in a commonplane, which can be oriented substantially perpendicular relative to alongitudinal axis of the prosthesis 105.

Optionally, the second end portion 212 can be shaped to include a seriesof peaks 230 and valleys 232, where second apices 236 of the supportframe 107 collectively form contours of the peaks 230 and valleys 232.The peaks 230 and valleys 232 of the second end portion 212 can bepositioned downstream of the first end portion 210 when the prosthesisis seated within the native valve annulus. In accordance with someembodiments, the prosthetic leaflets 109 can be coupled relative to thesupport frame 107 at locations circumferentially aligned with the peaks230 of the second end portion 212, as shown in FIG. 7F. This uniqueconfiguration can advantageously enable the prosthesis 100 to more fullyapproximate the native valve structures, permit a more natural bloodflow without limiting or otherwise constraining movement of the valveleaflets 109, and more seamlessly integrate with surroundingarchitecture of the heart.

In some embodiments, at the second end portion 212, an axial end of themembrane 108 can be shaped to cover the major peaks 230 and valleys 232of the second end portion 212. In some embodiments, the membrane 108 canbe shaped to cover the second apices or minor peaks 236 within thevalleys 232 between the major peaks 230. Advantageously, theconfiguration of the minor peaks 236 between the major peaks 230 canallow improved access to and prevent obstructions of the ostia comparedto prior art valve prostheses.

A prior art valve prosthesis, implanted within an aorta may block orobstruct the coronary ostia disposed a distance away from the valveannulus due to the geometry of the valve frame and the membrane, asdiscussed in Applicant's copending patent applications U.S. PatentApplication No. 62/614,488, filed on Jan. 7, 2018 (122271-5025), U.S.Patent Application No. 62/614,489, filed on Jan. 7, 2018 (122271-5040),U.S. Patent Application No. 62/756,556, filed on Nov. 6, 2018(122271-5127), and U.S. Patent Application No. 62/781,537, filed on Dec.18, 2018 (122271-5129), the entireties of which are incorporated hereinby reference.

Referring to FIG. 7F, the difference in height between the major peaks230 and the minor peaks 236 facilitates access to the coronary ostiawhile allowing for desired operation of the valve prosthesis 105. Insome embodiments, the minor peaks 236 are configured to be low enough toallow a variety of sizes and locations of the coronary ostia withrespect to the native valve annulus location of a patient.Advantageously, in some embodiments, the minor peaks 236 allow foraccess to ostia that are less than 10 mm, less than 8 mm, or less than 6mm in coronary ostia height, which are typically excluded byconventional available prostheses. The ostia height can be measured asthe vertical distance between the inferior edge of the coronary arteryostium and the aortic annular plane. Further, in some embodiments, theminor peaks 236 allow for access to ostia that are disposed at a loweraxial distance (or ostia height) relative to the valve annulus.Furthermore, in some embodiments, the valve prosthesis 105 can bearranged to be disposed lower in the valve annulus to allow greateraccess to the ostia. By providing minor peaks 236 between the majorpeaks 230, and optionally used with one or more other features discussedherein, access to the coronary ostia is preserved allowing for futureprocedures that may require access to the ostia, such as coronarystenting.

In accordance with some embodiments, the axial length of the supportframe 107 can vary between the major peaks 230, the minor peaks 236, andthe valleys 232.

For example, the axial length of the support frame 107 measured at themajor peaks 230 can be about 10% to about 50%, about 20% to about 40%,about 25% to about 35%, or about 33% greater than the axial lengthmeasured at the minor peaks 236.

Additionally, in some embodiments, the axial length of the support frame107 measured at the major peaks 230 can be about 50% to about 150%,about 70% to about 130%, about 90% to about 110%, or about 100% greaterthan the axial length measured at the valleys 232.

Further, in some embodiments, although the membrane 108 is illustratedas following the major peaks 230 and the minor peaks 236 along thesecond end portion 212 of the support frame 107, the membrane 108 canalso extend along the individual struts or frame members of the supportframe 107. Thus, the individual struts forming the support frame 107 candefine approximately the boundary of the membrane 108.

Additional aspects of the support frame 107, the membrane 108, and valveanchor 120 can be configured as discussed and illustrated in some ofApplicant's copending applications noted above, the entirety of which isincorporated herein by reference.

For example, in some embodiments, the membrane 108 can be formed ormanufactured by cutting the membrane 108 from a woven or mesh fabric.The membrane fabric can be a fabric formed from woven fiber, such aswoven polyester. As discussed and illustrated in some of Applicant'scopending applications noted above, the membrane fabric can be woventogether with fibers in a warp direction and a weft direction that areoriented transverse, and in some cases, perpendicular, relative to eachother. In some embodiments, a fabric may resist stretching in the warpand weft directions while allowing stretching and compliance indirections oblique to or biased from the warp and weft directions. Themembrane 108 and frame 107 can be configured as also disclosed in someof Applicant's copending applications noted above.

Optionally, one or more membranes 108 can be cut from the membranefabric using templates that are generally in the shape of the membrane.One or more templates can be placed on the membrane fabric to cut outthe membrane. The template can be oriented at an angle relative to themembrane fabric so that the membrane, when coupled to the support frame107, defines a bias angle between the warp or weft directions of thefibers of the membrane and the longitudinal axis of the support frame107. The bias angle can be from about 30 degrees to about 60 degrees,such as about 35 degrees, about 40 degrees, about 45 degrees, about 50degrees, or about 55 degrees.

In some embodiments, the warp and weft of the woven membrane 108 can beoriented relative to the longitudinal axis at a bias angle between 0 and90 degrees. In some embodiments, the woven membrane 108 can be orientedat a bias angle between about 15 and about 75 degrees relative to thelongitudinal axis. In some embodiments, the woven membrane 108 can beoriented at a bias angle between about 30 degrees and about 60 degreesrelative to the longitudinal axis. In some embodiments, the wovenmembrane 108 can be oriented at a bias angle of about 45 degreesrelative to the longitudinal axis.

By orienting the templates at a bias angle relative to the membranefabric, the resulting membrane 108 can be cut on the bias with the biasangle with respect to the warp and weft directions of the membranefabric. In some embodiments, the membrane 108 can be cut at the biasangle by spiral wrapping the membrane fabric onto the support frame 107and cutting the membrane fabric.

Through implementation of a bias orientation of fibers of the membrane108 on the support frame 107, the membrane 108 can more easily radiallycompress and axially elongate in tandem with the support frame 107, thuspermitting the membrane 108 and the support frame 107 to operate as asingle unit, in some embodiments. Similarly, in some embodiments, byorienting the membrane 108 along a bias angle, the membrane 108 can morereadily elongate along longitudinal axis to obtain a smallercross-sectional profile, which can prevent flaring, bunching, orpleating, thereby minimizing the cross-sectional profile of the valveprosthesis 105 in a compressed configuration.

Illustration of Subject Technology as Clauses

Various examples of aspects of the disclosure are described as numberedclauses (1, 2, 3, etc.) for convenience. These are provided as examples,and do not limit the subject technology. Identifications of the figuresand reference numbers are provided below merely as examples and forillustrative purposes, and the clauses are not limited by thoseidentifications.

Clause 1. A method of assembly for valve prosthesis delivery, the methodcomprising: coupling at least one suture to a support frame; and loopingthe at least one suture to an anchoring leg of a valve anchor so thatthe at least one suture is slidable along the anchoring leg.

Clause 2. The method of Clause 1, further comprising compacting thesupport frame and the valve anchor; and housing the compacted supportframe and the compacted valve anchor within a sheath with the supportframe coupled to the valve anchor via the at least one suture.

Clause 3. The method of Clause 1, further comprising inserting a pinthrough a connection aperture of the anchoring leg to constrain aportion of the anchoring leg.

Clause 4. The method of Clause 1, further comprising sliding the pinthrough the connection aperture and through a lock aperture.

Clause 5. The method of Clause 3, further comprising positioning theportion of the anchoring leg between a first flange and a second flange.

Clause 6. A method of assembly for valve prosthesis delivery, the methodcomprising: coupling a plurality of sutures to an end of a supportframe; looping the plurality of sutures to a plurality of anchoring legsof a valve anchor so that the plurality of sutures are slidable alongthe plurality of anchoring legs, wherein each of the anchoring legs isinterconnected between a pair of U-shaped members of the valve frame,and wherein each of the plurality of sutures are looped in a respectivelongitudinal slot extending along a length of the respective anchoringleg; compacting the support frame and the valve anchor; and housing thecompacted valve anchor and the compacted support frame slidably coupledto the compacted valve anchor within an outer sheath.

Clause 7. The method of Clause 6, further comprising arranging thecompacted valve anchor and the compacted support frame serially withinthe outer sheath.

Clause 8. The method of Clause 6, further comprising inserting aplurality of pins of a pin assembly through a plurality of connectionapertures of the plurality of anchoring legs to radially constrain anend of each of the anchoring legs.

Clause 9. The method of Clause 8, further comprising sliding theplurality of pins through the plurality of connection apertures andthrough a plurality of lock apertures.

Clause 10. The method of Clause 8, further comprising positioning theend of each of the anchoring legs between a first flange and a secondflange.

Clause 11. A system for valve prosthesis delivery comprising: a supportframe; a valve anchor comprising an anchoring leg and a plurality ofU-shaped members; and a suture coupled to the support frame and slidablycoupled to the anchoring leg.

Clause 12. The system of Clause 11, wherein the anchoring leg comprisesa longitudinal slot extending along a length of the anchoring leg,wherein the suture is slidably coupled along the longitudinal slot.

Clause 13. The system of Clause 11, further comprising a pin, whereinthe anchoring leg comprises a connection aperture and the pin extendsthrough the connection aperture to constrain a portion of the anchoringleg.

Clause 14. The system of Clause 11, further comprising a lock componentcomprising a lock aperture, wherein the pin further extends through thelock aperture.

Clause 15. The system of Clause 14, wherein the lock component comprisesa first flange portion, a second flange portion, and an engagementregion interposed between the first flange portion and the second flangeportion, wherein the lock aperture extends through the first flangeportion and the second flange portion, and wherein the portion of theanchoring leg is disposed in the engagement region.

Clause 16. The system of Clause 13, wherein the connection aperturecomprises a hole at an end of the anchoring leg.

Clause 17. The system of Clause 11, wherein the support frame has afirst end portion and a second end portion opposite to the first endportion, the suture is coupled to the first end portion, and the secondend portion has a plurality of major peaks and valleys and a pluralityof minor peaks between the plurality of major peaks.

Clause 18. The system of Clause 17, further comprising a membrane shapedto cover the minor peaks.

Clause 19. The system of Clause 11, wherein the valve anchor and thesupport frame are compacted within an outer sheath.

Clause 20. The system of Clause 19, wherein the valve anchor and thesupport frame coupled to the valve anchor are positioned serially withinthe outer sheath.

Clause 21. A system for valve prosthesis delivery comprising: a supportframe; a valve anchor comprising three anchoring legs and three U-shapedmembers interconnected between the three anchoring legs, wherein each ofthe anchoring legs has a proximal end attached to a U-shaped member, adistal end having a connection aperture, and a longitudinal slotextending along a length of the anchoring leg, such that the threeanchoring legs have three connection apertures and three longitudinalslots; and three suture loops coupled to the support frame and slidablycoupled to the three anchoring legs along the three longitudinal slots.

Clause 22. The system of Clause 21, further comprising a pin assemblyhaving an annular component and three pins extending proximally from aproximal face of the annular component, wherein the three pins extendthrough the three connection apertures to radially constrain the distalends of the three anchoring legs.

Clause 23. The system of Clause 22, further comprising a lock componentcomprising three lock apertures, wherein the three pins further extendthrough the three lock apertures.

Clause 24. The system of Clause 23, wherein the lock component comprisesa distal flange portion, a proximal flange portion, and an engagementregion interposed between the distal flange portion and the proximalflange portion, wherein the three lock apertures extend through thedistal flange portion and the proximal flange portion, and wherein thedistal ends of the three anchoring legs are disposed in the engagementregion.

Clause 25. The system of Clause 21, wherein the three connectionapertures comprise three holes extending through the distal ends of thethree anchoring legs.

Clause 26. The system of Clause 21, wherein the support frame has adistal end portion and a proximal end portion, the three suture loopsare coupled to the distal end portion, and the proximal end portion hasa plurality of major peaks and valleys and a plurality of minor peaksbetween the plurality of major peaks.

Clause 27. The system of Clause 26, further comprising a membranecovering the minor peaks.

Clause 28. The system of Clause 21, wherein the valve anchor and thesupport frame are compacted within an outer sheath.

Clause 29. The system of Clause 28, wherein the valve anchor and thesupport frame coupled to the valve anchor are positioned serially withinthe outer sheath with the valve anchor disposed distal to the supportframe.

Clause 30. The system of Clause 21, wherein each of the valve anchor andthe support frame are self-expanding components.

Clause 31. The system of Clause 30, wherein each of the valve anchor andthe support frame are made of nitinol.

Clause 32. The system of Clause 21, further comprising a pin assemblyhaving an annular component and three pins extending proximally from aproximal face of the annular component; and a lock component comprisinga distal flange portion, a proximal flange portion, an engagement regioninterposed between the distal flange portion and the proximal flangeportion, and three lock apertures extending through the distal flangeportion and the proximal flange portion, wherein the three pins extendthrough the three connection apertures and through the three lockapertures with the distal ends of the three anchoring legs disposed inthe engagement region to radially constrain the distal ends of the threeanchoring legs, and wherein each of the valve anchor and the supportframe are self-expanding components.

Clause 33. A method for delivering a valve prosthesis to a targetlocation in a vessel of a subject, the method comprising: introducing adelivery system into the vessel to position a valve anchor of the valveprosthesis at the target location; proximally retracting a sheath of thedelivery system to permit anchoring members of the valve anchor toexpand for anchoring the valve anchor at the target location; distallyadvancing a support frame of the valve prosthesis within the valveanchor while distally sliding a suture coupled to the support framealong an anchoring leg of the valve anchor; and expanding the supportframe within the valve anchor.

Clause 34. The method of Clause 33, wherein distally sliding the suturecomprises moving the suture from a proximal position in which the sutureprovides a radial restriction on a proximal portion of the valve anchorto a distal position in which the radial restriction is relieved tothereby permit radial expansion of the proximal portion of the valveanchor.

Clause 35. The method of Clause 34, further comprising: radiallyrestricting a distal portion of the anchoring leg with a pin extendingthrough a connection aperture of the anchoring leg when the suture is inthe proximal position; and disengaging the pin from the connectionaperture when the suture is in the distal position to permit radialexpansion of the distal portion of the anchoring leg.

Clause 36. The method of Clause 33, wherein distally sliding the suturecomprises sliding the suture along a longitudinal slot extending along alength of the anchoring leg.

Clause 37. The method of Clause 33, further comprising: radiallyrestricting a distal portion of the anchoring leg with an engagementmechanism during the distally sliding of the suture.

Clause 38. The method of Clause 33, wherein the expanding the supportframe comprises proximally retracting the sheath from over the supportframe to permit the support frame to self-expand within the valveanchor.

Clause 39. The method of Clause 33, wherein the target locationcomprises an aortic valve, wherein the anchoring members each comprise aU-shaped member, and wherein the method further comprises advancing theU-shaped members into respective aortic valve sinuses of the aorticvalve.

Further Considerations

In some embodiments, any of the clauses herein may depend from any oneof the independent clauses or any one of the dependent clauses. In someembodiments, any of the clauses (e.g., dependent or independent clauses)may be combined with any other one or more clauses (e.g., dependent orindependent clauses). In some embodiments, a claim may include some orall of the words (e.g., steps, operations, means or components) recitedin a clause, a sentence, a phrase or a paragraph. In some embodiments, aclaim may include some or all of the words recited in one or moreclauses, sentences, phrases or paragraphs. In some embodiments, some ofthe words in each of the clauses, sentences, phrases or paragraphs maybe removed. In some embodiments, additional words or elements may beadded to a clause, a sentence, a phrase or a paragraph. In someembodiments, the subject technology may be implemented without utilizingsome of the components, elements, functions or operations describedherein. In some embodiments, the subject technology may be implementedutilizing additional components, elements, functions or operations.

The foregoing description is provided to enable a person skilled in theart to practice the various configurations described herein. While thesubject technology has been particularly described with reference to thevarious figures and configurations, it should be understood that theseare for illustration purposes only and should not be taken as limitingthe scope of the subject technology.

There may be many other ways to implement the subject technology.Various functions and elements described herein may be partitioneddifferently from those shown without departing from the scope of thesubject technology. Various modifications to these configurations willbe readily apparent to those skilled in the art, and generic principlesdefined herein may be applied to other configurations. Thus, manychanges and modifications may be made to the subject technology, by onehaving ordinary skill in the art, without departing from the scope ofthe subject technology.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. The accompanying method claims presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

As used herein, the term “distal” can denote a location or directionthat is away from a point of interest, such as a control unit or regionof the delivery system that will be used to deliver a valve prosthesisto a native valve annulus. Additionally, the term “proximal” can denotea location or direction that is closer to a point of interest, such as acontrol unit or region of the delivery system that will be used todeliver a valve prosthesis.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “and” or “or” to separate any of the items,modifies the list as a whole, rather than each member of the list (i.e.,each item). The phrase “at least one of” does not require selection ofat least one of each item listed; rather, the phrase allows a meaningthat includes at least one of any one of the items, and/or at least oneof any combination of the items, and/or at least one of each of theitems. By way of example, the phrases “at least one of A, B, and C” or“at least one of A, B, or C” each refer to only A, only B, or only C;any combination of A, B, and C; and/or at least one of each of A, B, andC.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

Furthermore, to the extent that the term “include,” “have,” or the likeis used in the description or the claims, such term is intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically stated, but rather “one or more.”Pronouns in the masculine (e.g., his) include the feminine and neutergender (e.g., her and its) and vice versa. The term “some” refers to oneor more. Underlined and/or italicized headings and subheadings are usedfor convenience only, do not limit the subject technology, and are notreferred to in connection with the interpretation of the description ofthe subject technology. All structural and functional equivalents to theelements of the various configurations described throughout thisdisclosure that are known or later come to be known to those of ordinaryskill in the art are expressly incorporated herein by reference andintended to be encompassed by the subject technology. Moreover, nothingdisclosed herein is intended to be dedicated to the public regardless ofwhether such disclosure is explicitly recited in the above description.

Although the detailed description contains many specifics, these shouldnot be construed as limiting the scope of the subject technology butmerely as illustrating different examples and aspects of the subjecttechnology. It should be appreciated that the scope of the subjecttechnology includes other embodiments not discussed in detail above.Various other modifications, changes and variations may be made in thearrangement, operation and details of the method and apparatus of thesubject technology disclosed herein without departing from the scope ofthe present disclosure. Unless otherwise expressed, reference to anelement in the singular is not intended to mean “one and only one”unless explicitly stated, but rather is meant to mean “one or more.” Inaddition, it is not necessary for a device or method to address everyproblem that is solvable (or possess every advantage that is achievable)by different embodiments of the disclosure in order to be encompassedwithin the scope of the disclosure. The use herein of “can” andderivatives thereof shall be understood in the sense of “possibly” or“optionally” as opposed to an affirmative capability.

What is claimed is:
 1. A method of assembly for valve prosthesisdelivery, the method comprising: coupling a plurality of sutures to anend of a support frame; looping the plurality of sutures to a pluralityof anchoring legs of a valve anchor so that the plurality of sutures areslidable along the plurality of anchoring legs, wherein each of theanchoring legs is interconnected between a pair of U-shaped members ofthe valve anchor, wherein each of the plurality of sutures are looped ina respective longitudinal slot of the respective anchoring leg, and eachrespective longitudinal slot extends along a longitudinal length of thevalve anchor and wherein each respective suture is slidably coupledalong the respective longitudinal slot; compacting the support frame andthe valve anchor; and housing the compacted valve anchor and thecompacted support frame slidably coupled to the compacted valve anchorwithin an outer sheath.
 2. The method of claim 1, further comprisingarranging the compacted valve anchor and the compacted support frameserially within the outer sheath.
 3. The method of claim 1, furthercomprising inserting a plurality of pins of a pin assembly through aplurality of connection apertures of the plurality of anchoring legs toradially constrain an end of each of the anchoring legs.
 4. The methodof claim 3, further comprising sliding the plurality of pins through theplurality of connection apertures and through a plurality of lockapertures.
 5. The method of claim 3, further comprising positioning theend of each of the anchoring legs between a first flange and a secondflange.
 6. A system for valve prosthesis delivery comprising: a supportframe; a valve anchor comprising an anchoring leg and a plurality ofU-shaped members, wherein the anchoring leg comprises a longitudinalslot extending along a longitudinal length of the valve anchor; and asuture coupled to the support frame and slidably coupled to theanchoring leg along the longitudinal slot.
 7. The system of claim 6,further comprising: a pin, wherein the anchoring leg comprises aconnection aperture and the pin extends through the connection apertureto constrain a portion of the anchoring leg.
 8. The system of claim 7,further comprising a lock component comprising a lock aperture, whereinthe pin further extends through the lock aperture.
 9. The system ofclaim 8, wherein the lock component comprises a first flange portion, asecond flange portion, and an engagement region interposed between thefirst flange portion and the second flange portion, wherein the lockaperture extends through the first flange portion and the second flangeportion, and wherein the portion of the anchoring leg is disposed in theengagement region.
 10. The system of claim 6, wherein the support framehas a first end portion and a second end portion opposite to the firstend portion, the suture is coupled to the first end portion, and thesecond end portion has a plurality of major peaks and valleys and aplurality of minor peaks between the plurality of major peaks.
 11. Thesystem of claim 10, further comprising a membrane shaped to cover theminor peaks.
 12. The system of claim 6, wherein the valve anchor and thesupport frame are compacted within an outer sheath.
 13. A valve anchorfor a valve prosthesis, the valve anchor comprising U-shaped members andanchoring legs disposed in an alternating pattern about a longitudinalaxis of the valve anchor, each U-shaped member having a pair of peakportions and a base portion disposed between the peak portions, eachanchoring leg having first and second end sections, each first endsection being coupled to peak portions of adjacent U-shaped members,each second end section being opposite the first end section thereof andhaving a pin connection aperture that is couplable with a deliverysystem to permit each second end section to be actuated separately fromthe base portions of the adjacent U-shaped members thereby allowing thebase portions to flare out radially relative to the second end sectionswhile the second end sections remain engaged via the pin connectionapertures thereof with a valve prosthesis delivery system wherein eachanchoring leg comprises a slot extending between the first end sectionand the second end section, wherein a suture is slidably coupled alongeach slot.
 14. The valve anchor of claim 13, wherein the slot is closed.15. The valve anchor of claim 13, wherein the valve anchor comprisesthree anchoring legs and three U-shaped members.
 16. A valve prosthesiscomprising: a valve anchor comprising an anchoring leg and a pluralityof U-shaped members, the anchoring leg having a longitudinal slotextending along a longitudinal length of the valve anchor; and a supportframe having a plurality of prosthetic valve leaflets coupled thereto,the support frame being slidably coupled to the longitudinal slot of theanchoring leg for permitting longitudinal adjustability of the supportframe relative to the valve anchor.
 17. The prosthesis of claim 16,further comprising a suture that slidably couples the support frame tothe longitudinal slot of the anchoring leg.
 18. The prosthesis of claim16, wherein the valve anchor comprises three anchoring legs.
 19. Theprosthesis of claim 16, wherein the anchoring leg extends longitudinallybetween adjacent U-shaped members.
 20. The prosthesis of claim 16,wherein the support frame is rotatably adjustable relative to the valveanchor.
 21. The prosthesis of claim 16, wherein the anchoring legfurther comprises an aperture spaced longitudinally apart from thelongitudinal slot.